ClinicalTrials.gg
Status unknownNCT04531384Updated Dec 29, 2022

Robot-Assisted Intelligent Rehabilitation Treatment for Methamphetamine Use Disorders.

An interventional study of robot-assisted rehabilitation intelligent treatment and standard psychotherapy treatment in Amphetamine Addiction, sponsored by Shanghai Mental Health Center. Status unknown at 1 site in China. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2022-12-29.

Sponsored by Shanghai Mental Health Center · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

The purpose of this research is to evaluate the efficacy and safety of Robot-assisted rehabilitation intelligent system as a virtual stand-alone treatment, delivered with minimal clinical monitoring compared with treatment as usual in methamphetamine (MA) use disorders.

Read the detailed description

Based on artificial intelligence technology, face recognition technology, virtual reality technology to develop an available Robot-assisted rehabilitation intelligent system. Then, using this intelligent system as a new way of Psychotherapy to provide treatment for methamphetamine patients, and compare it with traditional treatment to verify the efficacy and safety of Robot-assisted rehabilitation intelligent system in Chinese methamphetamine patients.

02

Conditions studied

  • Amphetamine Addiction
03

In context

Amphetamine-Related Disorders

60 studies on the registry are indexed under Amphetamine-Related Disorders; 4 are open to participants now.

This study's planned enrollment of 200 is above the median of 48 across 53 interventional studies indexed under Amphetamine-Related Disorders.

Browse Amphetamine-Related Disorders studies →

Lead sponsor

Shanghai Mental Health Center is the lead sponsor of 271 studies on the registry; 91 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • In accordance with the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) for methamphetamine (MA) use disorders;
  • Education level equal or more than 9 years;
  • Have normal or corrected-to-normal vision;
  • Have normal or corrected-to-normal hearing;
  • Less than 3 months before last drug use;

Exclusion criteria

Exclusion Criteria:

  • Current substance use (except nicotine or caffeine);
  • History of disease which influence cognition,such as seizure disorder、cerebrovascular disease、head injury or other severe medication conditions;
  • Intelligence quotient less than 70.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    robot-assisted rehabilitation intelligent treatment

    Participants assigned to this condition were offered 10 weekly individual sessions of robot-assisted rehabilitation treatment, delivered by the Robot-assisted rehabilitation intelligent system. The system contains 10 core cognitive-behavioral therapy (CBT) skill topics (such as functional analysis, coping skills training, reviewing practice exercises, explaining CBT concepts). A robot therapist demonstrates the target CBT skills and assigns homework to participants.

    Device: robot-assisted rehabilitation intelligent treatment

  • Other
    treatment as usual

    Participants in the treatment-as-usual group were offered standard treatment at the compulsory isolated detoxification centers and non-compulsory isolated detoxification institutions, which consisted of weekly group and/or individual therapy, as determined by the clinical team.

    Other: standard psychotherapy treatment

Interventions

  • Devicerobot-assisted rehabilitation intelligent treatment

    robot-assisted rehabilitation psychotherapy

  • Otherstandard psychotherapy treatment

    standard treatment at the compulsory isolated detoxification centers and non-compulsory isolated detoxification institutions

06

What researchers measure

Primary outcomes

  1. Changes of galvanic skin response during the virtual reality based addiction assessment system

    The galvanic skin response is an emotional physiological indicator, and its unit is ohm.

    Time frame: in 1 year

Secondary outcomes

  1. Treatment motivation

    Using the Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES) to measure the treatment motivation of the participants. The score of the scale is between 19 and 95. The higher the score, the higher the treatment motivation.

    Time frame: in 1 year

  2. Anxiety

    Anxiety is assessed by the State-Trait Anxiety Scale (SAS). The score of the SAS scale is between 0 and 80. The higher the score, the more severe the anxiety symptoms.

    Time frame: in 1 year

  3. Depression

    Depression is assessed by the the Beck Depression Scale (SDS). The score of the SDS scale is between 0 and 80. The higher the score, the more severe the depression symptoms.

    Time frame: in 1 year

  4. Attentional bias related to drugs and emotional stimulation

    The emotional Stroop tests is used for assessed attentional bias. The indicator is the accuracy rate of the key presses, from 0 to 100%.

    Time frame: in 1 year

  5. Risky decision-making

    Balloon Analogue Risk Task is used for assess the risky decision-making ability. The indicator is the average number of balloon blows, and its unit is times.

    Time frame: in 1 year

  6. Reaction inhibition ability

    Stop signal task is used for assess the reaction inhibition ability. The indicator is the reaction time when the participant completes the task, and its unit is milliseconds.

    Time frame: in 1 year

  7. Changes of electroencephalogram power spectrum during the virtual reality based addiction

    The electroencephalogram power spectrum reflects the functional status of the brain, and its unit is uV\^2.

    Time frame: in 1 year

07

Study locations

1 of 1 sites recruiting
  • Shanghai Gaojing Rehabilitation Center
    Shanghai, 200030, China
    • Jianyan Dai · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Dec 2020 (actual). Primary completion is estimated for Dec 2022, 24 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 4, 2020
First posted
Aug 28, 2020
StartActual
Dec 1, 2020
Primary completionEst.
Dec 2022
CompletionEst.
Dec 2022
Last update
Dec 29, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 29, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04531384
Responsible party
Sponsor
First posted
Aug 28, 2020
Start date
Dec 1, 2020
Primary completion
Dec 2022 (estimated)
Completion
Dec 2022 (estimated)
Last update
Dec 29, 2022

Study contacts

Min Zhao
Contact
drminzhao@gmail.com
64387250
Min Zhao
principal investigator · Shanghai Mental Health Center

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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